關于藥用輔料品種備案情況的告知函
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南京化學試劑股份有限公司,藥用輔料品種備案情況告知如下:
藥用輔料備案產品清單1(液體輔料)(截止2020.12.03)
序號 | CAS號 | 產品名稱 | 英文名 | 登記號 | 執行標準 |
1 | 64-17-5 | 乙醇 | F20190001875、F20180000539 F20200000221、F20200000220 | ChP、USP、EP | |
2 | 64-17-5 | 無水乙醇 | Anhydrous Ethanol | F20190001876、F20180000538 F20190000633、F20190000687 | ChP、USP、EP |
3 | 乙酸乙酯 | Ethyl Acetate | F20190001877、F20180000657 F20190000609 | ChP、USP | |
4 | 異丙醇 | Isopropyl Alcohol | F20190001878、F20180000541 F20190000685、F20200000172 | ChP、USP、EP | |
5 | 丙二醇 | Propylene Glycol | F20190001879、F20180000542 | ChP | |
6 | 三氯甲烷 | Chloroform | F20190001880、F20170000574 F20190000693 | ChP、BP | |
7 | 冰醋酸 | Glacial Acetic Acid | F20190001881、F20180000649 F20190000465 | ChP、EP | |
8 | 醋酸 | Acetic Acid | F20190001882、F20180000648 | ChP | |
9 | 稀醋酸 | Diluted Acetic Acid | F20190001883、F20180000653 | ChP | |
10 | 102-76-1 | 甘油三乙酯 | Triacetin | F20200000163 | ChP |
11 | 丙酮 | Acetone | F20190000097、F20190000466 | EP、USP | |
12 | 107-15-3 | 乙二胺 | Ethylenediamine | F20190000116、F20200000273 F20200000274 | ChP、USP、EP |
13 | 67-56-1 | 甲醇 | Methanol | F20190000117、F20200000173 | EP、USP |
14 | 75-09-2 | 二氯甲烷 | Methylene Chloride | F20190000300 | EP |
15 | 7664-38-2 | 磷酸 | Phosphoric Acid | F20190000008、F20200000547 F20200000551 | ChP、USP、EP |
16 | 鹽酸 | Hydrochloric Acid | F20170000438、F20190001884 F20200000219、F20200000218 | ChP、USP、EP | |
17 | 稀鹽酸 | Diluted Hydrochloric Acid | F20190001885、F20180000545 | ChP | |
18 | 硫酸 | Sulfuric Acid | F20190001886、F20180000647 F20200000217 | ChP、EP | |
19 | 7664-41-7 | 濃氨溶液 | Strong Ammonia Solution | F20190001887、F20180000586 F20190000686 | ChP、EP |
20 | — | 稀氨溶液 | Dilute Ammonia Solution | F20190000349 | ChP |
藥用輔料備案產品清單2(固體輔料)(截止2020.12.03)
序號 | CAS號 | 產品名稱 | 英文名 | 登記號 | 執行標準 |
1 | 苯甲酸鈉 | Sodium Benzoate | F20190001888、F20180000643 F20200000275 | ChP、USP | |
2 | 依地酸二鈉 | Disodium Edetate | F20190001889、F20170000439 F20190000076 | ChP、USP | |
3 | 醋酸鈉 | Sodium Acetate | F20190001890、F20180000323 | ChP | |
4 | 無水醋酸鈉 | Sodium Acetate Anhydrous | F20180000640 | ChP | |
5 | 無水碳酸鈉 | Anhydrous Sodium Carbonate | F20190001891、F20180000641 | ChP | |
6 | 無水亞硫酸鈉 | Anhydrous Sodium Sulfite | F20190001892、F20180000642 | ChP | |
7 | 磷酸氫二鈉十二水合物 | Disodium Hydrogen Phosphate Dodecahydrate | F20190001893、F20180000645 | ChP | |
8 | 無水磷酸氫二鈉 | Disodium Hydrogen Phosphate Anhydrous | F20190001894、F20180000646 | ChP | |
9 | 13472-35-0 | 磷酸二氫鈉二水合物 | Sodium Dihydrogen Phosphate Dihydrate | F20200000142、F20200000164 | ChP、EP |
10 | 磷酸二氫鈉一水合物 | Sodium Dihydrogen Phosphate Monohydrate | F20190001895、F20180000644 | ChP | |
11 | 磷酸氫二鉀 | Dipotassium Hydrogen Phosphate | F20190001896、F20180000638 | ChP | |
12 | 磷酸氫二鉀三水合物 | Dipotassium Hydrogen Phosphate Trihydrate | F20190001897、F20180000639 | ChP | |
13 | 磷酸二氫鉀 | Potassium Dihydrogen Phosphate | F20190001898、F20180000637 | ChP | |
14 | 山梨酸鉀 | Potassium sorbate | F20190001899、F20180000635 | ChP | |
15 | 22500-92-1 | 山梨酸 | Sorbic acid | F20190001900、F20180000540 | ChP |
16 | 枸櫞酸 | Citric Acid | F20190001901、F20180000656 | ChP | |
17 | DL-酒石酸 | DL-Tartaric Acid | F20190001902、F20180000655 | ChP | |
18 | 尿素 | Urea | F20190001903、F20180000582 | ChP | |
19 | 琥珀酸 琥珀酸(口服) | Succinic Acid | F20180001223 F20180001730 | ChP | |
20 | 硫酸鈣 | Calcium Sulfate | F20190000375 | ChP | |
21 | 7783-20-2 | 硫酸銨 | Ammonium Sulfate | F20190000652 | ChP |
22 | 6153-56-6 | 草酸二水合物 | Oxalic Acid Dihydrate | F20190000749 | 企標 |
23 | 62-33-9 | 依地酸鈣鈉 | Calcium Disodium Edetate | F20200000509、F20200000510 | ChP、USP |